Device recall
Z-2761-2017: Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part…
FDA device recall · Class II · Atrium Medical Corporation
Key facts
| Recall number (Z-number) | Z-2761-2017 |
|---|---|
| Recall event | 77342 |
| Product | Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only) Atrium Advanta V12 Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85355 (Marketed OUTSIDE U.S. only) The iCAST Covered Stent is indicated for the treatment of… |
| Product code | JCT |
| Recalling firm | Atrium Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 26, 2020 |
| 510(k) numbers | K050814 |
| FEI number | 3011175548 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database